Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: The SpondyloArthritis Research Consortium of Canada (SPARCC) score of the sacroiliac joints (SIJ) is often used in clinical trials to detect changes over time. It is important to know if the SPARCC score spontaneously change over time in patients on non-biological treatment. We investigated how much change in the SPARCC score of the SIJ can be detected over a 3-month period in patients on non-biological treatment.
Methods: Ninety patients with chronic back pain (≥3 months, but ≤2 years, onset <45 years) in the SPondyloArthritis Caught Early (SPACE)-cohort underwent a baseline and 3-month follow-up MRI of the SIJ (MRI-SIJ). All MRI-SIJs were scored according to the SPARCC score by 2 independent readers, blinded for time sequence. The mean SPARCC scores (2 readers) were used in this analysis. Delta scores in SPARCC between both time points were calculated. Patients were treated by their rheumatologist, who was unaware of the MRI scores; treatment was recorded.
Results: In 45 (50%) patients (41 patient with a SPARCC score of 0; 2 with a SPARCC score of 1; 2 with a SPARCC score ≥2), the SPARCC score did not change over the period of 3 months. In 18 (20%) patients, the SPARCC score changed 1 point (increased in 10 and decreased in 8 patients). In 27 (30%) patients the SPARCC score changed ≥2 points (13 patients showed an increase and 14 patients a decrease). In the patients that showed a change, the mean (SD) change in score was -0.7 (6.0), the median (range; IQR) change was -1 (-17 to 16; -3 to 1.3).
In the 45 patients without SPARCC score changes, 10 (11%) patients did not use any medication, 16 (18%) patients were on stable non-biological treatment, and 19 (21%) changed treatment (9 patients switched NSAIDs, 5 started NSAID treatment, 4 stopped treatment with NSAIDs, 1 patient started NSAIDs and stopped after 2 months during the follow-up period).
Of all patients (n=45) with SPARCC score changes, 10 (11%) patients did not use any medication, 22 (24%) patients were on stable non-biological treatment, and 13 (14%) patients changed treatment during the 3-month period. Eight of them switched to another NSAID (SPARCC score decreased 1 point in 3 patients, 4 points in 1 patient and 6 points in another patient, and increased 1 and 2 points in the remaining patients). Four patients started treatment with NSAIDs, and SPARCC score decreased in all of them (17 points, 3 points, 2 points and 1 point). One patient stopped NSAID treatment and SPARCC score increased 1 point.
Conclusion: Over a short period of 3 months, the SPARCC score changed without the start of a TNF-blocker in 45 patients (50%) on non-biological treatment, with a range from -17 to 16 points. The observed changes in SPARCC score do not seem to be influenced by non-biologic treatment. While analyzing results of clinical trials, it is important to keep in mind that a change in SPARCC score in patients on non-biological treatment is possible. This is important information for the power calculation of a trial.
|
Treatment over the 3-month period (baseline – follow-up) |
No SPARCC score change, n=45 |
SPARCC score change, n=45 |
|
|
Decrease, n=22 |
Increase, n=23 |
||
|
No medication, n=20 |
10 |
3* |
7* |
|
Stable non-biological treatment, n=38 |
16 |
9* |
13* |
|
Switch NSAIDs, n=17 |
9 |
6* |
2* |
|
Start NSAID, n=9 |
5 |
4* |
– |
|
Stop NSAID, n=5 |
4 |
– |
1† |
|
Start and stop NSAID, n=1 |
1 |
– |
– |
|
*Range 1-17 points, †1 point |
|||
Disclosure:
R. van den Berg,
None;
M. de Hooge,
None;
V. Navarro-Compán,
None;
F. van Gaalen,
None;
M. Reijnierse,
None;
T. Huizinga,
None;
D. van der Heijde,
None.
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